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An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121588
First received: May 10, 2010
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.


Condition Intervention Phase
Neoplasms Malignant
Drug: Crizotinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1b Open-label Study Of The Safety And Clinical Activity Of Crizotinib (Pf-02341066) In Tumors With Genetic Events Involving The Anaplastic Lymphoma Kinase ( Alk) Gene Locus

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Overall Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Plasma concentrations of crizotinib [ Time Frame: 30 Months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Proportion of patients with each of the ALK genetic events [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • Progression-Free Survival (PFS) [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when available [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crizotinib Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Other Name: PF-02341066

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of malignancy other than NSCLC
  • positive for translocation or inversion event involving the ALK gene locus
  • positive for ALK amplification events
  • positive for ALK activating point mutations

Exclusion Criteria:

  • mutations of amplifications involving the c-Met gene but not the ALK gene
  • concurrent treatment on another therapeutic clinical trial
  • prior therapy specifically directed against ALK
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121588

Locations
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
United States, Missouri
Site Cancer Center - West County
Creve Coeur, Missouri, United States, 63141
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
Greenville Hospital System, Institute for Translational Oncology Research
Greenville, South Carolina, United States, 29605
China, Guangdong
Sun Yat-Sen university cancer center
Guangzhou, Guangdong, China, 510060
China
Cancer institute and hospital, Chinese academy of Medical Sciences.
Beijing, China, 100021
Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, Italy, 20900
Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Russian Federation
Research Institute of Pulmonology
Saint-Petersburg, Russian Federation, 197089
St.-Petersburg State Medical University I.P.Pavlov of Roszdrav
Saint-Petersburg, Russian Federation, 197022
Taiwan
National Taiwan University Hospital, Department of Internal Medicine
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121588     History of Changes
Other Study ID Numbers: A8081013, PROFILE 1013, 2010-022978-14
Study First Received: May 10, 2010
Last Updated: October 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
neoplasm malignant
lymphoma
neuroblastoma
Crizotinib
anaplastic lymphoma kinase
ALK

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lymphoma
Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Immune System Diseases
Immunoproliferative Disorders
Lung Diseases
Lung Neoplasms
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Crizotinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014